Clinical Trial: Balloon Tamponade for Atonic Primary Postpartum Hemorrhage

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Comparison of Condom-Loaded Foley's Catheter Versus Bakri Balloon for Treatment of Primary Postpartum Hemorrhage: A Randomized Controlled Trial

Brief Summary:

Postpartum hemorrhage (PPH) is responsible for around 25% of maternal mortality worldwide reaching as high as 60% in some countries.PPH can also be a cause of long-term severe morbidity, and approximately 12% of women who survive PPH will have severe anemia.

Postpartum hemorrhage has been defined as blood loss in excess of 500 ml in a vaginal birth and in excess of 1 L in a cesarean delivery.For clinical purposes, any blood loss that has the potential to produce hemodynamic instability should be considered a PPH. However, clinical estimates of blood loss are often inaccurate. Primary (immediate) PPH occurs within the first 24 hours after delivery and approximately 70% of these cases are due to uterine atony. Furthermore, uterine tony is defined as the failure of the uterus to contract adequately after the child is born.

Guidelines for the management of postpartum hemorrhage (PPH) involve a stepwise approach including the exclusion of retained products of conception and genital tract trauma. Uterine atony, which is the most common cause, the management of uterine atony is an established stepwise protocol that in many international guidelines.

Uterine massage is recommended for the treatment of PPH. Initiate uterine massages soon as excessive bleeding/uterine atony is identified. Intravenous oxytocin alone still is the recommended uterotonic drug for the treatment of PPH.

If intravenous oxytocin is unavailable or if the bleeding does not respond to oxytocin, intravenous ergometrine, oxytocin-ergometrine fixed dose or a prostaglandin drug (including sublingual misoprostol, 600 mcg) should be given. The use of intrauterine balloon tamponade is recommended for the treatment of primary PPH due to uterine atony in women who do not

Detailed Summary:
Sponsor: Assiut University

Current Primary Outcome: Number of patients who need surgical intervention to stop the bleeding [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time between insertion and stoppage of bleeding (minutes) [ Time Frame: 1 year ]
  • Number of patients who need a blood transfusion [ Time Frame: 1 year ]
  • Number of patients who developed fever [ Time Frame: 1 year ]
  • The amount of blood loss (ml) after application of the balloon [ Time Frame: 1 year ]
  • Number of patients who referred to Intensive care unit [ Time Frame: 1 year ]
  • Number of patients who developed disseminated intravascular coagulopathy [ Time Frame: 1 year ]
  • Duration (minutes) of bleeding after deflation of the balloon [ Time Frame: 1 year ]
  • amount of bleeding (ml) after deflation of the balloon [ Time Frame: 1 year ]


Original Secondary Outcome: Same as current

Information By: Assiut University

Dates:
Date Received: March 24, 2015
Date Started: July 2014
Date Completion:
Last Updated: April 25, 2015
Last Verified: March 2015